Current Status and Development Trends of International Procurement of Medical Devices (2025)
#Company news ·2022-09-02 11:40:58
1、 Global Market Overview and Trade Trends
In 2025, the global medical device trade will show a parallel trend of recovery and structural adjustment. As a core participant, China's total import and export volume of medical devices in the first half of the year reached 38.256 billion US dollars, including exports of 21.794 billion US dollars and imports of 16.462 billion US dollars. The Asian market accounts for 32.75% of China's exports, Europe accounts for 41.66% of imports, and the United States remains the largest single trading partner. The export of diagnostic and therapeutic equipment increased by 8.2%, with significant growth in high-end products such as surgical robots; Imports are mainly focused on medical equipment. Exports to the "the Belt and Road" countries increased by 9.35% year on year, and African markets such as Morocco became new growth points.
2、 International breakthrough of intelligent medical devices
With the penetration of AI technology, intelligent devices have become a new engine for international procurement. China's AI medical device exports increased by 5.38% year-on-year in the first quarter, and products such as medical imaging dedicated chips and AI health management systems have passed the EU MDR and US FDA certifications. Enterprises such as Yuyue Medical have optimized blood glucose meters, ventilators, and other equipment through algorithms, and their overseas revenue has reached 30%. Intelligent products account for over 40% of diagnostic and therapeutic exports, with high-end categories such as surgical robots driving an average export price increase of 3.6%.
3、 Policy environment and compliance challenges
The imposition of tariffs by the United States has led to a 6.34% decrease in exports to the United States, but companies have mitigated the impact through Mexico's transit and development of non US markets. The EU's new regulations require government procurement projects worth over 45 million yuan to exclude EU enterprises, forcing domestic procurement to shift towards localized substitution. Export needs to simultaneously meet multiple standards such as EU MDR, US 510 (k), and ASEAN CSDT. About 40% of enterprises experience certification delays due to incomplete documents.
4、 Future Development Trends
The combination of medical large-scale models and hardware will enhance the diagnostic accuracy of equipment and further open up the high-end markets in Europe and America. RCEP regional capacity cooperation deepens, and Southeast Asia will become a core production base for mid to low end consumables. The differentiated implementation of ISO 13485 and national regulations remains a major pain point, and there is an urgent need to establish a cross-border mutual recognition mechanism.